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Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome

Primary Purpose

Piriformis Muscle Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
corticosteroid injection
dry needling
exercise
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Muscle Syndrome focused on measuring piriformis syndrome, steroid injection, dry needling, exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18-60, Hip pain for ≥1 month Local piriformis pain with prolonged sitting (>20 minutes) and increased sensitivity Patients with suspected piriformis syndrome based on clinical maneuvers Signing and informed consent from showing consent to participate in the study Exclusion Criteria: Hip surgery Lumbar disc disease History of inflammatory hip disease Medical treatment for pain is started Neurological deficit Breastfeeding or pregnant Allergy to local anesthetic Use of anticoagulants Body mass index >35 Active psychiatric illness Uncontrolled hypertension and diabetes mellitus disease Noncompensated chronic lung/heart/renal failure History of vascular/tumoral disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Other

    Arm Label

    corticosteroid group

    dry needling group

    control group

    Arm Description

    In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)

    In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)

    The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS) (Sitting)
    Average hip pain intensity in a sitting position over the past 24 hours, a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
    Visual Analog Scale (VAS) (Resting)
    Average hip pain intensity at rest over the past week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
    Visual Analog Scale (VAS) (Movement)
    Average hip pain intensity during movement over the past 1 week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)

    Secondary Outcome Measures

    Oswestry disability index (ODI)
    ODI includes questions regarding pain severity, sexual function, sleep quality and personal care, ability to work, sit, walk, lift, stand and travel. Total score ranges from 0-50, with higher scores indicating more injury.

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095180
    Brief Title
    Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
    Official Title
    Comparison of Efficacy of Ultrasound-Guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 28, 2023 (Anticipated)
    Primary Completion Date
    August 26, 2024 (Anticipated)
    Study Completion Date
    August 26, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome.
    Detailed Description
    Piriformis syndrome is a painful entrapment neuropathy caused by compression of the sciatic nerve under the piriformis muscle. The most common cause is myofascial pain syndrome. There is no gold standard treatment for piriformis syndrome. The main purpose of treatment methods is to reduce local pain, muscle tension and spasm. This work; it will contribute to the literature by comparing steroid, dry needling and exercise treatments in patients with piriformis syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Piriformis Muscle Syndrome
    Keywords
    piriformis syndrome, steroid injection, dry needling, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    corticosteroid group
    Arm Type
    Active Comparator
    Arm Description
    In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
    Arm Title
    dry needling group
    Arm Type
    Active Comparator
    Arm Description
    In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.
    Intervention Type
    Other
    Intervention Name(s)
    corticosteroid injection
    Intervention Description
    In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
    Intervention Type
    Other
    Intervention Name(s)
    dry needling
    Intervention Description
    In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS) (Sitting)
    Description
    Average hip pain intensity in a sitting position over the past 24 hours, a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
    Time Frame
    at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks
    Title
    Visual Analog Scale (VAS) (Resting)
    Description
    Average hip pain intensity at rest over the past week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
    Time Frame
    at baseline and change from baseline VAS (resting) at 4 weeks and 12 weeks
    Title
    Visual Analog Scale (VAS) (Movement)
    Description
    Average hip pain intensity during movement over the past 1 week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
    Time Frame
    at baseline and change from baseline VAS (movement) at 4 weeks and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Oswestry disability index (ODI)
    Description
    ODI includes questions regarding pain severity, sexual function, sleep quality and personal care, ability to work, sit, walk, lift, stand and travel. Total score ranges from 0-50, with higher scores indicating more injury.
    Time Frame
    at baseline and change from baseline ODI at 4 weeks and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18-60, Hip pain for ≥1 month Local piriformis pain with prolonged sitting (>20 minutes) and increased sensitivity Patients with suspected piriformis syndrome based on clinical maneuvers Signing and informed consent from showing consent to participate in the study Exclusion Criteria: Hip surgery Lumbar disc disease History of inflammatory hip disease Medical treatment for pain is started Neurological deficit Breastfeeding or pregnant Allergy to local anesthetic Use of anticoagulants Body mass index >35 Active psychiatric illness Uncontrolled hypertension and diabetes mellitus disease Noncompensated chronic lung/heart/renal failure History of vascular/tumoral disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayşenur Şimşek Yağlıoğlu, MD
    Phone
    +903122912444
    Email
    aysenursimsek33@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayşenur Şimşek Yağlıoğlu, MD
    Organizational Affiliation
    Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome

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